search
Back to results

A Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Combination With Chemotherapy in Patients With Relapsed or Metastatic Ovarian Cancer, Endometrial Cancer, and Cervical Cancer ( PORCH ) (PORCH)

Primary Purpose

1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ATG-008
ATG-010
Sponsored by
Qi Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Understand and voluntarily sign informed consent (ICF).
  2. Age 18 to 70 (including 18 and 70).
  3. Histopathological or clinical diagnosis of high grade relapsed or metastatic serous ovarian cancer (including fallopian tube cancer and peritoneal cancer), endometrial cancer (including endometrial carcinosarcoma) and cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma); received ≤1 line treatment after recurrence.
  4. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or

1. 6. Life expectancy >3 months. 7. Women of childbearing potential must agree to use effective contraceptives from signing the informed consent until 180 days after the last dose of study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative blood pregnancy test at screening

Exclusion Criteria:

  • 1. Histopathological diagnosis of sarcoma, carcinosarcoma (except endometrial carcinosarcoma). 2. Low-grade serous carcinoma, clear cell carcinoma, and mucinous carcinoma. 3. Symptomatic central nervous system metastases (except those who have been previously treated for brain metastases but have been keeping stable of disease status for 4 weeks prior to screening). 4. Participated in other clinical trials within 4 weeks prior to screening. 5. Received major surgery within 4 weeks prior to screening or expect to proceed a major surgical treatment during the study period. 6. Received systemic chemotherapy, radiotherapy, traditional Chinese medicine with anti tumor indications within 4 weeks prior to screening, or plan to receive therapeutic radiotherapy during the study period. 7. Received live attenuated vaccine within 4 weeks before screening, or plan to receive live attenuated vaccine during screening. 8. Using systemic immunosuppressive drugs currently or used within two weeks before screening with the following exceptions:

    1. Intranasal, inhaled, topical steroid or topical steroid injection (eg, intraarticular),
    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/ day of prednisone or equivalent, OR
    3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication). 9. Suffer from swallowing dysfunction, active gastrointestinal diseases or other diseases or disorders that affect the absorption, distribution, metabolism, and excretion of ATG-008 or ATG 010. 10. Hepatitis B virus (HBV) infection (Hepatitis B surface antigen [HBsAg] positive) or active hepatitis C virus (HCV) infection (HCVRNA positive at screening).

      11. Subjects with a history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 12. Hypersensitive or known to be allergic to ATG-008, ATG-010 or chemotherapeutic agents or to active or inactive ingredients of drugs with similar chemical structures. 13. Have a history of organ transplantation (eg, liver transplantation or autologous stem cell transplantation). 14. Known as alcohol or drug dependent. 15. Female subjects who are pregnant or lactating. 16. Judgment by the investigator that the subject should not participate in the study by consideration of the complications or other conditions which might affect their adherence to the protocol.

Sites / Locations

  • Chongqing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ATG-008 + Chemotherapeutics

ATG-010 + Chemotherapeutics

Arm Description

ATG-008: Oral, 30 mg QD+Paclitaxel: 175 mg/m2, intravenous infusion >3 h, Day 1, Q3W; ATG-008: Oral, 30 mg QD+Carboplatin: AUC = 5, intravenous infusion >1 h, Day 1, Q3W or Cisplatin: 75 mg/m2, intravenous infusion >1h, Day 2, Q3W ; ATG-008: Oral, 30 mg QD+Doxorubicin hydrochloride liposome, 40 mg/m2, Day 1; Q4W;

perimental: ATG-010 + Chemotherapeutics ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Paclitaxel: 175 mg/m2, intravenous infusion >3 h, Day 1, Q3W; ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Carboplatin: AUC = 5, intravenous infusion >1 h, Day 1, Q3W or Cisplatin: 75 mg/m2, intravenous infusion >1h, Day 2, Q3W ; ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Doxorubicin hydrochloride liposome, 40 mg/ m2, Day 1; Q4W;

Outcomes

Primary Outcome Measures

Objective response rate(ORR)
Objective response rate(ORR)

Secondary Outcome Measures

Time to response(TTR)
Evaluated by investigators according to RECIST 1.1
Duration of Response(DOR)
Evaluated by investigators according to RECIST 1.1
Disease control rate(DCR)
Evaluated by investigators according to RECIST 1.1
Overall Survival(OS)
The estimates of Kaplan-Meier
Progression-Free Survival(PFS)
Evaluated by investigators according to RECIST 1.1
The incidence,severity,and causality of AE,SAE
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
EORTC-QLQ-C30
To evaluate the safety and tolerability of ATG-008 or ATG-010 in

Full Information

First Posted
August 4, 2021
Last Updated
August 4, 2021
Sponsor
Qi Zhou
search

1. Study Identification

Unique Protocol Identification Number
NCT04998760
Brief Title
A Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Combination With Chemotherapy in Patients With Relapsed or Metastatic Ovarian Cancer, Endometrial Cancer, and Cervical Cancer ( PORCH )
Acronym
PORCH
Official Title
A Multi-center Clinical Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Combination With Chemotherapy in Patients With Relapsed or Metastatic Ovarian Cancer, Endometrial Cancer, and Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 3, 2021 (Anticipated)
Primary Completion Date
January 9, 2024 (Anticipated)
Study Completion Date
April 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qi Zhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
1. This is a multi-center clinical study to evaluate dual mTORC1/2 inhibitor (ATG 008) or selective inhibitor of nuclear export compound (ATG-010) in combination with chemotherapy in patients with relapsed or metastatic ovarian cancer, endometrial cancer, and cervical cancer.
Detailed Description
This is a multi-center clinical study to evaluate dual mTORC1/2 inhibitor (ATG 008) or selective inhibitor of nuclear export compound (ATG-010) in combination with chemotherapy in patients with relapsed or metastatic ovarian cancer, endometrial cancer, and cervical cancer. And two cohorts of ATG-008 30 mg QD or ATG-010 80 mg QW in combination with chemotherapy will enroll subjects with platinum-sensitive ovarian cancer, platinum-resistant ovarian cancer, endometrial cancer, and cervical cancer, with about 8-12 subjects in either cohort. A total of about 64-96 subjects plan to be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ATG-008 + Chemotherapeutics
Arm Type
Experimental
Arm Description
ATG-008: Oral, 30 mg QD+Paclitaxel: 175 mg/m2, intravenous infusion >3 h, Day 1, Q3W; ATG-008: Oral, 30 mg QD+Carboplatin: AUC = 5, intravenous infusion >1 h, Day 1, Q3W or Cisplatin: 75 mg/m2, intravenous infusion >1h, Day 2, Q3W ; ATG-008: Oral, 30 mg QD+Doxorubicin hydrochloride liposome, 40 mg/m2, Day 1; Q4W;
Arm Title
ATG-010 + Chemotherapeutics
Arm Type
Experimental
Arm Description
perimental: ATG-010 + Chemotherapeutics ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Paclitaxel: 175 mg/m2, intravenous infusion >3 h, Day 1, Q3W; ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Carboplatin: AUC = 5, intravenous infusion >1 h, Day 1, Q3W or Cisplatin: 75 mg/m2, intravenous infusion >1h, Day 2, Q3W ; ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Doxorubicin hydrochloride liposome, 40 mg/ m2, Day 1; Q4W;
Intervention Type
Drug
Intervention Name(s)
ATG-008
Intervention Description
ATG-008 will be orally administered at 30 mg QD combined with chemotherapies. And about 8-12 subjects plan in each cohort.
Intervention Type
Drug
Intervention Name(s)
ATG-010
Intervention Description
ATG-010 will be orally administered at 30 mg QD and 80 mg QW combined with chemotherapies. And about 8-12 subjects plan in each cohort.
Primary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
Objective response rate(ORR)
Time Frame
26 months
Secondary Outcome Measure Information:
Title
Time to response(TTR)
Description
Evaluated by investigators according to RECIST 1.1
Time Frame
26 months
Title
Duration of Response(DOR)
Description
Evaluated by investigators according to RECIST 1.1
Time Frame
26 months
Title
Disease control rate(DCR)
Description
Evaluated by investigators according to RECIST 1.1
Time Frame
26 months
Title
Overall Survival(OS)
Description
The estimates of Kaplan-Meier
Time Frame
26 months
Title
Progression-Free Survival(PFS)
Description
Evaluated by investigators according to RECIST 1.1
Time Frame
26 months
Title
The incidence,severity,and causality of AE,SAE
Description
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
Time Frame
26 months
Title
EORTC-QLQ-C30
Description
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
Time Frame
26 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understand and voluntarily sign informed consent (ICF). Age 18 to 70 (including 18 and 70). Histopathological or clinical diagnosis of high grade relapsed or metastatic serous ovarian cancer (including fallopian tube cancer and peritoneal cancer), endometrial cancer (including endometrial carcinosarcoma) and cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma); received ≤1 line treatment after recurrence. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Life expectancy >3 months. 7. Women of childbearing potential must agree to use effective contraceptives from signing the informed consent until 180 days after the last dose of study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative blood pregnancy test at screening Exclusion Criteria: 1. Histopathological diagnosis of sarcoma, carcinosarcoma (except endometrial carcinosarcoma). 2. Low-grade serous carcinoma, clear cell carcinoma, and mucinous carcinoma. 3. Symptomatic central nervous system metastases (except those who have been previously treated for brain metastases but have been keeping stable of disease status for 4 weeks prior to screening). 4. Participated in other clinical trials within 4 weeks prior to screening. 5. Received major surgery within 4 weeks prior to screening or expect to proceed a major surgical treatment during the study period. 6. Received systemic chemotherapy, radiotherapy, traditional Chinese medicine with anti tumor indications within 4 weeks prior to screening, or plan to receive therapeutic radiotherapy during the study period. 7. Received live attenuated vaccine within 4 weeks before screening, or plan to receive live attenuated vaccine during screening. 8. Using systemic immunosuppressive drugs currently or used within two weeks before screening with the following exceptions: Intranasal, inhaled, topical steroid or topical steroid injection (eg, intraarticular), Systemic corticosteroids at physiologic doses not to exceed 10 mg/ day of prednisone or equivalent, OR Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication). 9. Suffer from swallowing dysfunction, active gastrointestinal diseases or other diseases or disorders that affect the absorption, distribution, metabolism, and excretion of ATG-008 or ATG 010. 10. Hepatitis B virus (HBV) infection (Hepatitis B surface antigen [HBsAg] positive) or active hepatitis C virus (HCV) infection (HCVRNA positive at screening). 11. Subjects with a history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 12. Hypersensitive or known to be allergic to ATG-008, ATG-010 or chemotherapeutic agents or to active or inactive ingredients of drugs with similar chemical structures. 13. Have a history of organ transplantation (eg, liver transplantation or autologous stem cell transplantation). 14. Known as alcohol or drug dependent. 15. Female subjects who are pregnant or lactating. 16. Judgment by the investigator that the subject should not participate in the study by consideration of the complications or other conditions which might affect their adherence to the protocol.
Facility Information:
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Combination With Chemotherapy in Patients With Relapsed or Metastatic Ovarian Cancer, Endometrial Cancer, and Cervical Cancer ( PORCH )

We'll reach out to this number within 24 hrs